Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda

NCT ID: NCT05462509

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2021-12-15

Brief Summary

In this mixed methods study, the investigators assessed feasibility of use of the PATH bCPAP kit on neonatal patients as well as the usability and acceptability of the device by healthcare workers.The study took place in a rural Ugandan special care nursery with experience in bCPAP. Neonates with respiratory failure were consented and treated with the PATH bCPAP kit and blenders. The investigators conducted prospective data collection of the device use through observation as well as collected qualitative data via interviews with nurses, which were analyzed using a rapid qualitative analytical method.

Detailed Description

Preterm birth is responsible for 1/3 of deaths under age five- the majority which occur in resource-constrained settings. Many of these deaths are due to respiratory failure which can be treated with bubble continuous positive airway pressure (bCPAP). Commercialized bCPAP devices are expensive, leading resource-constrained settings to make and use improvised devices. These improvised devices have not been tested for performance and run on 100% oxygen. WHO guidelines strongly advise against the use of 100% oxygen-particularly with preterm newborns where it can cause blindness, lung and brain injury.

To address this need, PATH has developed a low-cost bCPAP kit which includes oxygen blenders that do not require electricity nor a source of pressurized air to blend oxygen with air. The objectives of this early feasibility study are to:

1. assess the operational feasibility of using the PATH bCPAP kit including, when appropriate, in-line oxygen blending on neonatal patients and

2. assess the usability and acceptability of the PATH bCPAP kit with oxygen blenders by healthcare workers.

Newborns will be treated with the PATH bCPAP kit and a subset of these will also be treated with the PATH blender as needed to provide blended oxygen. Results from this study will be used to identify appropriate modification to the use procedures and/or the device as needed. Once testing is completed and product revision finalized, the PATH kit and blenders will allow resource-constrained settings to provide rigorously tested bCPAP therapy and blended oxygen to patients with reduced risk of morbidity from oxygen toxicity.

Conditions

Respiratory Distress Syndrome; Infant, Premature

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

bCPAP and blenders

all patients admitted to the newborn care unit with respiratory failure will be evaluated for treatment with bCPAP per unit standards. All patients that meet treatment criteria will receive bCPAP. Patients for whom consent is available will be enrolled and start bCPAP therapy with the PATH kit. Patients for whom consent is not given or not available will start Kiwoko bCPAP. Patients who began bCPAP therapy with the Kiwoko kit and obtain consent within 24 hours of starting their bCPAP therapy may switch from Kiwoko to PATH bCPAP. Patients with >24 hours of Kiwoko bCPAP therapy are no longer eligible for enrolment. , oxygen blending for patients treated with PATH bCPAP will occur by the following two methods- and will be used in this order of preference:

1. blending via air compressor (standard of care in unit and used when available)

2. blending via PATH blender (when no compressor available)

Group Type: EXPERIMENTAL

bCPAP with blenders

Intervention Type: DEVICE

The intervention device is a low-cost bCPAP kit which includes two fixed-ratio oxygen blenders that do not require a source of pressurized air. These simple and inexpensive devices sit in-line from the oxygen source and dilute the flowing stream of oxygen with room air, obviating the need for a pressurized source of air. The oxygen may be supplied from either high-pressure sources or low-pressure sources such as oxygen concentrators. Each of the two blenders are single plastic parts, injection moulded from a biocompatible, medical-grade polyethylene resin. No electricity is required for the blenders to provide a stable and constant mix of air and oxygen over the full range of clinically relevant pressure and flows for newborns.

Interventions

bCPAP with blenders

The intervention device is a low-cost bCPAP kit which includes two fixed-ratio oxygen blenders that do not require a source of pressurized air. These simple and inexpensive devices sit in-line from the oxygen source and dilute the flowing stream of oxygen with room air, obviating the need for a pressurized source of air. The oxygen may be supplied from either high-pressure sources or low-pressure sources such as oxygen concentrators. Each of the two blenders are single plastic parts, injection moulded from a biocompatible, medical-grade polyethylene resin. No electricity is required for the blenders to provide a stable and constant mix of air and oxygen over the full range of clinically relevant pressure and flows for newborns.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Newborns <44 weeks post menstrual age with respiratory failure requiring treatment with bCPAP therapy during the period of study
• Parent or legal guardian consented to participation in the study within 24 hours of bCPAP initiation.

Exclusion Criteria

• No parental nor legal guardian consent for participation in the study.

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 44 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Adara Development

UNKNOWN

Sponsor Role: collaborator

Kiwoko Hospital

UNKNOWN

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kiwoko Hospital

Kiwoko, Nakaseke, Uganda

Countries

Uganda

References

Hedstrom AB, Nyonyintono J, Saxon EA, Nakamura H, Namakula H, Niyonshaba B, Nakakande J, Simpson N, Vaughan M, Wollen A, Mubiri P, Waiswa P, Coffey PS, Batra M. Feasibility and usability of a very low-cost bubble continuous positive airway pressure device including oxygen blenders in a Ugandan level two newborn unit. PLOS Glob Public Health. 2023 Mar 8;3(3):e0001354. doi: 10.1371/journal.pgph.0001354. eCollection 2023.

Reference Type: DERIVED

PMID: 36963078 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1519912-11

Identifier Type: -

Identifier Source: org_study_id